Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT04350567
Eligibility Criteria:
Inclusion criteria for depressed and non-depressed individuals
* Consent form signed
* Capacity to give informed consent
* Age 18 years or older (inclusive)
* Diagnosis of MDD and currently in a major depressive episode (depressed participants only)
* Score of at least twenty-nine on the MADRS (depressed participants only)
Exclusion Criteria:
* Participant considered at significant risk for suicide
* Unlikely to tolerate medication washout or the drug free period following washout (depressed participants only)
* Current psychosis
* ECT within 4 weeks of the first overnight visit
* Significant active physical illness or neurological deficit that may affect brain function or imaging
* A disease, job or life circumstance that creates an irregular circadian rhythm anticipated during the study
* Inability to maintain in bed and out of bed (regardless of sleep time, for depressed individuals) or sleep and wake times (for non-depressed individuals) to within \~30 min for a week before each overnight visit (will be measured by actigraphy and/or other measurements)
* Inability to abstain from medications that will affect glutamate levels or circadian rhythms, including stimulants, anti-epileptics, antidepressants, beta-blockers, hypnotics (including benzodiazepines), melatonin, or medications with glutamateric or GABAergic modes of action within 4 weeks before the first overnight visit as well as throughout the study
* Inability to reduce caffeine intake to \<= \~300 mg of caffeine (\~2.5 cups of coffee or equivalents) daily within 4 weeks of the first overnight visit as well as throughout the study
* Inability to abstain from nicotine within 4 weeks before the first overnight visit as well as throughout the study
* Inability to reduce use of alcohol to \<= \~5 drinks per week from 4 weeks before the first overnight visit and throughout the study and to completely abstain from alcohol within 24 hours of any overnight visit
* Inability to abstain from significant substance use (including cannabis) within 4 weeks before the first overnight visit as well as throughout the study
* Planned intermittent fasting or calorie restricted diet within 4 weeks before the first overnight visit as well as throughout the study
* For females: Pregnancy within the past year, currently lactating; planning to conceive during the course of study participation, or abortion in the past two months
* Any MRI contraindications, including metal implants, pacemaker, metal prostheses, orthodontic appliances, or presence of shrapnel that are contraindicated for MRI
* Any PET contraindications, including if study imaging will result in the participant receiving greater exposure than the research limit, or if participant is currently breastfeeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04350567
Study Brief:
Protocol Section:
NCT04350567